Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
STA-4783 and Paclitaxel for Treatment of Solid Tumors
This study has been completed.
Sponsored by: Synta Pharmaceuticals, Corp.
Information provided by: Synta Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT00088114
  Purpose

The purpose of this study is to determine the safety, toxicity and maximum tolerated dose of single doses of STA-4783/paclitaxel in combination when administered intravenously to patients with refractory cancer. To determine the pharmacokinetics of STA-4783 and paclitaxel when co-administered.

To assess the anti-tumor activity of STA-4783 and paclitaxel when co-administered.


Condition Intervention Phase
Neoplasms
Drug: STA-4783/paclitaxel
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title: A Phase I Trial of STA-4783 in Patients Receiving Paclitaxel for Treatment of Solid Tumors

Further study details as provided by Synta Pharmaceuticals, Corp.:

Estimated Enrollment: 50
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients greater than or equal to 18 years of age with histologically confirmed malignancy that is metastatic or unresectable and for which no standard therapy exists.
  • Patients must not have received prior chemotherapy or radiation for greater than or equal to 4 weeks before study enrollment.
  • Patients may be entered if they have received prior radiation therapy involving less than or equal to 30% of the bone marrow. Any prior radiation therapy must have been administered greater than or equal to 4 weeks before study enrollment and the patient must be recovered from the acute toxic effects of the treatment prior to study entry.
  • Patients may be enrolled with a history of treated brain metastases that are clinically stable for greater than or equal to 4 weeks prior to enrollment.
  • ECOG Performance Status of less than or equal to 2.
  • Life expectancy of greater than 12 weeks.
  • No peripheral neuropathy > grade 1 on NCI CTC version 2 scale, no history of stroke or other significant neurological limitations as determined by the investigator.
  • Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below.
  • Absolute neutrophil count greater than or equal to 1,500/ul
  • Platelets greater than or equal to 100,000 cells/ul
  • Total bilirubin must be within normal limits
  • AST(SGOT) less than or equal to 2.5 times the upper limit of normal
  • Serum creatinine < 1.5 mg/dl or a measured creatine clearance greater than or equal to 50 mL/min
  • Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by investigator.
  • The effects of STA-4783 on the developing human fetus are unknown, however taxanes are known to be teratogenic. Therefore, women of childbearing potential (defined as women less than or equal to 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Women who are pregnant or lactating.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patients with previous high dose chemotherapy with autologous stem cell rescue bone marrow transplantation.
  • Use of any investigational agents within 4 weeks of study enrollment.
  • History of severe allergic reactions to paclitaxel or docetaxel including severe hypersensitivity reactions defined as greater than or equal to 3 based on NCI CTC version 2.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088114

Locations
United States, Massachusetts
Beth Israel-Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Synta Pharmaceuticals, Corp.
  More Information

Study ID Numbers: 4783-01
Study First Received: July 20, 2004
Last Updated: October 5, 2007
ClinicalTrials.gov Identifier: NCT00088114  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Paclitaxel

Additional relevant MeSH terms:
Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009